Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
FDA Recall Z-2645-2017 · Posted 2017-06-27
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQO
Date Initiated2016-12-15
Date Terminated2018-04-10
Product Quantity39 boxes of 5 (195 units)
Reason for Recall
A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
Firm Action
Customers were sent an Urgent Medical Device Removal letter, dated 12/15/2016, via overnight mail delivery beginning 12/15/2016. The letter identified affected product, described the issue, and asked for product to be returned. Removal instructions were provided and a Reply Verification Tracking Form was asked to be returned. Questions can be directed to Nicole Pshon, Field Action Manager at 763-494-1133 or [email protected]
Root Cause
Employee error
Distribution Pattern
CA, FL, KY, MO, NM, OK, OR, PA, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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